The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for aflibercept 8 mg (Eylea®, Bayer) for the treatment of visual impairment due to macularedema secondary to retinal vein occlusion (RVO), including branch, central and hemiretinal vein occlusion. The decision marks the third licensed retinal indication for the higher-dose formulation in the UK.
The approval is based on data from the Phase III QUASAR trial, a multicenter, randomized, double-blind study in treatment-naïve patients with RVO. Aflibercept 8 mg met its primary endpoint at week 36, demonstrating non-inferior visual acuity gains compared with aflibercept 2 mg administered monthly. By week 64, patients receiving 8 mg after three initial monthly injections required an average of 8.4 injections versus 11.7 in the 2 mg arm.
Durability was a key differentiator. More than 60 percent of patients in the 8 mg three-month loading arm achieved a last assigned treatment interval of four months or longer at week 64, with 40 percent reaching five-month intervals. Fluid reduction and anatomical outcomes were comparable to the 2 mg regimen, and the safety profile was consistent with previous aflibercept 8 mg studies.
In parallel, the licensed posology for aflibercept 8 mg in neovascular AMD and diabetic macular edema has been updated to allow a minimum treatment interval of four weeks.
With RVO often requiring intensive early treatment, the authorization introduces a higher-dose anti-VEGF option positioned to reduce injection burden while maintaining visual outcomes – a development likely to be closely watched by NHS retinal services under capacity pressure.
Source: Bayer.
